1.1 本文件提供了在γ、X射线（韧致辐射）和电子束设施中辐照的产品、材料或物质中确定吸收剂量分布（映射）的指南。 注1: 对于食品辐照和医疗保健产品的辐射灭菌，存在包含剂量映射要求的特定ISO和ISO/ASTM标准。见ISO/ASTM惯例 51431 , 51608 , 51649 , 51702 和 51818 和ISO 11137-1。关于医疗保健产品的辐射灭菌，在ISO 11137-1涵盖的领域，该标准优先。 1.2 本指南是一套标准之一，提供了在辐射处理中正确实施剂量测定的建议。本标准旨在与ISO/ASTM一起阅读 52628 . 1.3 描述了分析剂量图数据的方法。提供了可用于分析剂量图数据的统计方法示例。 1.4 未讨论大流量处理和流体流的剂量映射。 1.5 剂量测定是辐照设施全面质量管理体系的一个要素。对于医疗器械灭菌和食品保存等特定应用，可能需要剂量测定以外的其他控制。 1.6 本标准并非旨在解决与其使用相关的所有安全问题（如有）。本标准的用户有责任在使用前制定适当的安全和健康实践，并确定监管要求的适用性。 ====意义和用途====== 4.1 本指南是为在辐射处理中正确实施剂量测定提供建议的一套指南和实践之一。为了理解并有效使用本标准和其他剂量学标准，请考虑第一个“辐射处理中的剂量学实践”，ASTM/ISO 52628 ，描述了根据ASTM E10.01系列剂量测定标准进行吸收剂量测量时适用的基本要求。此外，ASTM/ISO 52628 提供关于剂量测定系统选择的指南，并指导用户使用其他标准，这些标准提供了有关单个剂量测定系统、校准方法、不确定度估计和辐射处理应用的信息。 4.2 辐射处理在固定路径条件下进行，其中( 一 )通过机械方式或( b )在工艺开始之前，通过手动将产品放置在预定位置，静态辐照工艺负荷。在这两种情况下，过程的控制方式应确保过程载荷位置和方向在规定范围内可再现。 注2: 静态辐照包括使用手动旋转、无旋转或自动旋转的过程负载辐照。 4.3 一些利用固定输送机路径进行常规处理的辐射处理设施也可以表征辐射场内用于静态辐射处理的区域，有时称为“离载体”处理。 4.4 许多辐射处理应用需要最小吸收剂量（以实现预期效果或满足法律要求）和最大吸收剂量（以确保产品、材料或物质仍符合功能规范或满足法律要求）。 4.5 来自剂量图的信息用于: 4.5.1 表征辐射过程并评估吸收剂量值的再现性，其可作为操作鉴定和性能鉴定的一部分。 4.5.2 确定整个过程负荷中吸收剂量的空间分布以及最大和最小吸收剂量的区域，该区域可能由实际或模拟产品组成。 4.5.3 建立常规监测位置的剂量与为过程负荷建立的最小和最大剂量区内的剂量之间的关系。 4.5.4 验证数学剂量计算方法。见ASTM指南 E2232 . 4.5.5 确定过程中断对吸收剂量分布的影响以及最小和最大剂量的大小。 4.5.6 评估从一个过程负荷过渡到另一个过程负荷（例如，产品密度或产品负荷模式可能发生变化）时对吸收剂量分布的影响以及最小和最大剂量的大小。

1.1 This document provides guidance in determining absorbed-dose distributions (mapping) in products, materials or substances irradiated in gamma, X-ray (bremsstrahlung) and electron beam facilities. Note 1: For irradiation of food and the radiation sterilization of health care products, specific ISO and ISO/ASTM standards containing dose mapping requirements exist. See ISO/ASTM Practices 51431 , 51608 , 51649 , 51702 and 51818 and ISO 11137-1. Regarding the radiation sterilization of health care products, in those areas covered by ISO 11137-1, that standard takes precedence. 1.2 This guide is one of a set of standards that provides recommendations for properly implementing dosimetry in radiation processing. it is intended to be read in conjunction with ISO/ASTM 52628 . 1.3 Methods of analyzing the dose map data are described. Examples are provided of statistical methods that may be used to analyze dose map data. 1.4 Dose mapping for bulk flow processing and fluid streams is not discussed. 1.5 Dosimetry is an element of a total quality management system for an irradiation facility. Other controls besides dosimetry may be required for specific applications such as medical device sterilization and food preservation. 1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory requirements prior to use. ====== Significance And Use ====== 4.1 This guide is one of a set of guides and practices that provide recommendations for properly implementing dosimetry in radiation processing. In order to understand and effectively use this and other dosimetry standards, consider first “Practice for Dosimetry in Radiation Processing,” ASTM/ISO 52628 , which describes the basic requirements that apply when making absorbed dose measurements in accordance with the ASTM E10.01 series of dosimetry standards. In addition, ASTM/ISO 52628 provides guidance on the selection of dosimetry systems and directs the user to other standards that provide information on individual dosimetry systems, calibration methods, uncertainty estimation and radiation processing applications. 4.2 Radiation processing is carried out under fixed path conditions where ( a ) a process load is automatically moved through the radiation field by mechanical means or ( b ) a process load is irradiated statically by manually placing product at predetermined positions before the process is started. In both cases the process is controlled in such a manner that the process load position(s) and orientation(s) are reproducible within specified limits. Note 2: Static irradiation encompasses irradiation of the process load using either manual rotation, no rotation or automated rotation. 4.3 Some radiation processing facilities that utilize a fixed conveyor path for routine processing may also characterize a region within the radiation field for static radiation processing, sometimes referred to as “Off Carrier” processing. 4.4 Many radiation processing applications require a minimum absorbed dose (to achieve a desired effect or to fulfill a legal requirement), and a maximum absorbed dose (to ensure that the product, material or substance still meets functional specifications or to fulfill a legal requirement). 4.5 Information from the dose mapping is used to: 4.5.1 Characterize the radiation process and assess the reproducibility of absorbed-dose values, which may be used as part of operational qualification and performance qualification. 4.5.2 Determine the spatial distribution of absorbed doses and the zone(s) of maximum and minimum absorbed doses throughout a process load, which may consist of an actual or simulated product. 4.5.3 Establish the relationship between the dose at a routine monitoring position and the dose within the minimum and maximum dose zones established for a process load. 4.5.4 Verify mathematical dose calculation methods. See ASTM Guide E2232 . 4.5.5 Determine the effect of process interruptions on the distribution of absorbed dose and the magnitude of the minimum and maximum doses. 4.5.6 Assess the impact on the distribution of absorbed dose and the magnitude of the minimum and maximum doses resulting from the transition from one process load to another where changes, for example, in product density or product loading pattern may occur.